Event Notification Report for March 10, 2025

DAMAGED I-125 SEED

The following information was provided by the licensee via phone and email:

"During a surgical excision procedure [that occurred on 5/20/2022] in the operating room (OR), a lesion which was previously localized with an I-125 seed was extracted from the patient. A trunode [gamma probe] device was used to identify the location of the seed and to guide the surgeon for the dissection of the breast tissue. After the dissection, the physician visualized the seed on the outside of the tissue specimen while it was still within the breast. Once the specimen was removed and scanned, there were no counts obtained in the patient. The specimen was then placed in a faxitron [x-ray machine] and an image was taken, but no visualization of the seed [occurred]. The surgeon immediately scanned the breast tissue to evaluate if the seed had been left behind. There were zero counts within the breast. The physician then scanned the drapes and sponges and did not identify the seed. The surgeon then proceeded to scan the suction tubing and ultimately the manifold of the suction equipment and was able to identify the seed in the manifold. The OR team then contacted nuclear medicine [personnel] and informed them to secure the suction manifold and secure it in the specimen safe in the frozen room. The manifold was placed in a red biohazard bag and secured in the safe. The operating room and the suction equipment were then surveyed by the surgical techs; the room and equipment measurements were background.

"A nuclear medicine technologist retrieved the manifold from the safe and took the manifold to histopathology to remove the seed. The manifold had to be opened with a screwdriver and trained personnel in histopathology removed the seed. The seed was recovered, but it was in two pieces. One half was the titanium capsule, and the other half was the titanium capsule and the silver rod with the chemically affixed iodine-125. The two halves were then placed in a lead pig. The biohazard bag, manifold, and contents of the manifold measured radioactive and were labeled and placed in storage in the nuclear medicine hot lab.

"All personnel in histopathology and the nuclear medicine technologist were checked for radioactive contamination. Everyone was negative for radioactive contamination. The trash and work area were also tested and were negative. The nuclear medicine technologist then notified his direct report authorized user (AU), the surgeon, and the radiation safety officer (RSO). The AU and surgeon, after hearing the seed was in two halves, made the decision to recall the patient to the hospital to verify background for a third time. The survey was again background, and the AU determined to not initiate potassium iodide treatment regimen. The RSO and nuclear medicine technologist then surveyed the OR personnel, biohazard containers, surgical trash, and operating room. All measurements were background. Wipe tests were performed of the neptune suction machine and the I-125 source. The wipe test of the Neptune was background, and the wipe test of the source indicated to be I-125.

"The RSO has been in constant communication with an Ohio Medical Physicist Consultant (OMPC) health physicist, to make sure all protocols were followed correctly. The RSO also contacted the NRC regional III Health Physicist, to see if this is an incident that needs to be reported to the NRC. 10 CFR part 20, 30 and 35 were reviewed over the phone and it was determined at that time the broken seed was not a reportable event. The NRC regional III Health Physicist later emailed OMPC health physicist with two other reporting requirements for review to determine if a report was needed. After reviewing 10 CFR 30.50 and 10 CFR 35.3067 it was determined it was not a reportable event. The seed and the contaminated suction module will be stored in the nuclear medicine hot lab until it is deemed safe to dispose of properly."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:

The I-125 seed contained an estimated activity of 291 microcuries.

AGREEMENT STATE REPORT - MEDICAL EVENT

The following is a summary of information provided by the State of Florida, Bureau of Radiation Control (the BRC) via email:

"[BRC was notified of a medical event involving a high dose rate (HDR) prostate treatment that] occurred on 2/25/25, was identified during the weekend of 3/1/25 to 3/2/25, and was determined to have been a medical event by the facility on 3/3/25. During [delivery of] the second fraction of two fractions, Comprehensive Hematology Oncology incorrectly typed the catheter length into the procedure's software. This resulted in the dose being received 5 cm short of the intended location. The prostate received no dose during this fraction, and the rectum received an estimated 60 percent of its expected dose. The patient and primary physician have been notified. The second fraction has been rescheduled."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:

The prescribed dose for the second fraction of the HDR prostate treatment was unknown at the time of the notification. This event is similar but involved a different patient than EN 57581 (FL25-019).

Florida Incident Number: FL25-018

* * * UPDATE ON 03/04/2025 AT 0847 FROM MONROE COOPER TO ROBERT THOMPSON * * *

Current information, retrieved by BRC, states that the intended total dose was 2700 cGy delivered over two fractions.

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

AGREEMENT STATE REPORT - MEDICAL EVENT

The following is a summary of information provided by the State of Florida, Bureau of Radiation Control (the BRC) via email:

"[BRC was notified of a medical event involving a high dose rate (HDR) prostate treatment that] occurred on 2/25/25, was identified during the weekend of 3/1/25 to 3/2/25, and was determined to have been a medical event by the facility on 3/3/25. During [delivery of] the second fraction of two fractions, Comprehensive Hematology Oncology incorrectly typed the catheter length into the procedure's software. This resulted in the dose being received 5 cm short of the intended location. The prostate received no dose during this fraction, and the rectum received an estimated 60 percent of its expected dose. The patient and primary physician have been notified. The second fraction has been rescheduled."

The following additional information was obtained from the licensee in accordance with Headquarters Operations Officers Report Guidance:

The prescribed dose for the second fraction of the HDR prostate treatment was unknown at the time of the notification. This event is similar but involved a different patient than EN 57580 (FL25-018).

Florida Incident Number: FL25-019

* * * UPDATE ON 03/04/2025 AT 0847 FROM MONROE COOPER TO ROBERT THOMPSON * * *

Current information, retrieved by BRC, states that the intended total dose was 2700 cGy delivered over two fractions.

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.